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Thursday, June 27, 2013

Book raises alarms about alternative medicine - USA Today

The 12-year-old girl arrived at the hospital wracked with abdominal pain.

Doctors diagnosed her with acute pancreatitis, in which pancreatic enzymes begin digesting not just food, but the pancreas itself.

The most likely cause of the girl's condition: toxic side effects from more than 80 dietary supplements, which the girl's mother carried in a shopping bag, says Sarah Erush, clinical pharmacy manager at Children's Hospital of Philadelphia, where the girl was treated last summer.

The girl's mother had been treating her with the supplements and other therapies for four years to treat the girl's "chronic Lyme disease," a condition that, experts say, doesn't actually exist. While some Lyme infections cause pain and other lingering symptoms, the infections don't persist for years. And, according to the Infectious Disease Society of America, the infections don't require years of antibiotics or other risky therapies given by some alternative medicine practitioners.

Doctors were able to control the girl's illness with standard therapies, Erush says, and she was discharged from the hospital after two weeks.

Although the child's story was unforgettable, Erush says, it wasn't unusual. Parents now "routinely" bring children to her hospital with a variety of alternative remedies, hoping that nurses will administer them during a child's stay.

There are an ever-growing number of supplements from which to choose: More than 54,000 varieties sold in stores and the Internet, according to the Food and Drug Administration.

About 50% of Americans use alternative medicine, and 10% use it on their children, notes Paul Offit, Children's Hospital's chief of infectious disease.

The girl's story illustrates the serious but often little-known risks posed by some forms of alternative medicine, a loosely regulated industry that includes everything from herbal supplements to crystal healing and acupuncture, says Offit, author of Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine, (HarperCollins, $29.99), being published Tuesday

Many consumers view alternative medicine industry as more altruistic and home-spun than Big Pharma. But in his book, Offit paints a picture of an aggressive, $34 billion a year industry whose key players are adept at using lawsuits, lobbyists and legislation to protect their market.

"It's a big business," says Offit, best known for developing a vaccine against rotavirus, a diarrheal illness that killed 2,000 people each day, mostly children in the developing world.

"This is not just Mom and Pop selling herbs at the farmer's market," says Josephine Briggs, a physician and director of the National Center on Complementary and Alternative Medicine, part of the National Institutes of Health, who shares Offit's concerns.

Rep. Henry Waxman, D-Calif., who has long fought for stricter regulation of supplements, says the alternative medicine industry is "as tough as any industry I've seen lobby in Washington. They have a lot of money at stake. They want to maximize their profits and they want as little regulation as possible."

There's even a Congressional Dietary Supplement Caucus, composed of legislators who look favorably on the industry.

Combined with alternative therapy research at the National Cancer Institute, the NIH spends a total of $233 million a year on this research, which has included everything from herbal supplements to acupuncture and aromatherapy.

Briggs notes that research conducted by her center and others shows real benefits to certain alternative therapies, which doctors describe as "complementary" if they are used in conjunction with conventional medicine. Last year, for example, The New England Journal of Medicine published a study showing that people with Parkinson's disease can improve their balance and stability by practicing Tai Chi, an ancient Chinese exercise system. A study published last month in the Journal of the American Medical Association found that intensive-care patients on ventilators experienced less anxiety, and required fewer sedatives, if they could listen to their choice of music.

Proponents of alternative medicine say there are clear reasons for its popularity, including frustration with mainstream doctors and people's desire to have more control over their health.

Only about one-third of alternative therapies have safety and efficacy data behind them, critics note. Yet conventional doctors don't always follow the evidence, either, says Adriane Fugh-Berman, an associate professor of pharmacology at Georgetown University in Washington and author of a textbook on herbs and supplements. Only about one-quarter of therapies used in conventional medicine are "evidence-based," she says.

Many Americans see modern medicine as increasingly bureaucratic and impersonal, says Deepak Chopra, a physician and one of the best known advocates for mind-body healing.

"Doctors spend more time filling in charts than they spend on seeing patients," Chopra says. "The average doctor stands in the door and does a ritual of examining patients for one or two minutes, then moves on to the next patient."

"Medicine does a very poor job of addressing the emotional, spiritual and even psychological side of things," Caplan says. "When you are not good at doing important things, other people rush into that vacuum."

Yet people who put their faith in alternative healers and supplements may be putting themselves at risk, Caplan says.

The alternative therapy industry capitalizes on a number of common sentiments, Offit says, from a naïve belief in the safety of all things natural to distrust of government regulation.

"Just because it comes from a plant, doesn't mean it's not harmful," Chopra says.

About one-third of conventional drugs are derived from plants, Fugh-Berman says. Pharmaceutical companies still make Digoxin, a heart drug, from the foxglove flower, she says. And while some research suggests that kava, a plant in the pepper family, can relieve anxiety, it can also damage the liver.

In the best cases, Offit says, alternative remedies are ineffective but relatively harmless, functioning as expensive placebos that may appear to relieve symptoms such as pain, largely because people expect them to. An example of this is homeopathy, in which key ingredients are diluted to the point of oblivion, making these remedies basically sugar pills, Offit says.

Yet supplements aren't risk-free.

A 2010 report from the Government Accountability Office found supplements were being sold with deceptive marketing practices.

Tests have found heavy metals in ayurvedic medicines, used in India for thousands of years to treat a variety of conditions and also popular in the USA, Briggs says.

In some cases, dietary supplements are just prescription medications in disguise.

The most common offenders tend to be supplements claiming to aid weight loss, build muscles or boost sexual performance, Briggs says. Although such supplements may be marketed as "natural," the FDA has found hundreds of brands actually contain real drugs, from anabolic steroids to the active ingredient in Viagra. Several weight-loss supplements were found to contain the active ingredient in Meridia, a prescription diet drug pulled from the market due to an increased risk of heart attack and stroke.

In April, the FDA announced that it had received 86 reports of illness and death due to body-building supplements that illegally contained a stimulant called DMAA. The FDA says DMAA, which is especially risky when combined with caffeine, can raise blood pressure, leading to problems such as shortness of breath and heart attacks.

In 2012, the FDA estimated that supplements cause 50,000 adverse reactions a year.

Nissen says he's lost patients with serious cardiovascular disease because they opted to take alternative medicines instead of those he prescribed. The practice, Nissen says, is "a national catastrophe in the making."

Alternative medicine doctors sell patients on a variety of unproven therapies, such as chelation, a process of removing metals from the blood, Offit says.

Although chelation has real medical uses — treating acute heavy metal poisoning — doctors also promote the intravenous treatments as an alternative remedy for everything from Alzheimer's disease to cancer.

In 2005, a 5-year-old boy with autism died after treatment with chelation, according to the Centers for Disease Control and Prevention.

Many people with aches and pains are being misdiagnosed with chronic Lyme disease, Offit says, even though studies show that half of these patients really suffer from treatable conditions, such as depression or rheumatoid arthritis. Doctors who call themselves "Lyme literate" often prescribe years of intravenous antibiotics, a therapy with no proven benefits but serious side effects, including infections and the risk of developing antibiotic resistance.

Jobs was diagnosed with pancreatic cancer in 2003. But Jobs, revered as one of the brightest minds on the planet, chose to delay surgery, the only treatment that had a chance to save his life, Cassileth says.

For nine months after his diagnosis, Offit writes, Jobs treated his cancer with acupuncture, herbs, bowel cleansings and a special diet of carrots and fruit juices.

Jobs eventually had surgery, and even a liver transplant. But it was too late.

He died in 2011, eight years after diagnosis.

"He had the only kind of pancreatic cancer that is treatable and curable," Cassileth says. "He essentially committed suicide."

Cancer patients have cashed in their life savings or children's college funds to pay charismatic charlatans, spending $20,000 or more for "absurd" treatments at fringe clinics in the USA, Mexico and Bahamas, Cassileth says.

"There are no viable alternatives to mainstream cancer care," Cassileth says. "We work very hard to dissuade patients who want to go that way, because they are going to die."

And while many in the alternative medicine industry are cashing in, Offit says there are few people looking out for the desperate patients whose hopes — and bank accounts — are being exploited.

"Quackery is an enormous concern," Briggs says.

Consumers are often taken in by outrageous claims, partly because they lack the scientific knowledge to spot phonies, and partly because they fall victim to a huckster's charismatic personality, Offit says.

"Our science literacy is terrible as a nation," Briggs says. "People like magic. I don't know why, but they do."

Many Americans are unaware that supplements, unlike drugs, don't need to be approved by the Food and Drug Administration — or tested for safety — before going on the market, Offit says. One study found that 58% of Americans believe that the FDA must approve herbal supplements before they're sold.

"When a consumer buys a food supplement or dietary supplement, they may think it's really going to do what it says on the label," Waxman says. "That's not necessarily the case. ... Consumers should know that when they buy a dietary supplement, they are really on their own."

And while manufacturers are responsible for making sure that products are safe, the FDA can typically take action only after products are on store shelves.

The FDA expressed frustration with these constraints in an April press release about DMAA.

In making the announcement, the agency said, "FDA is required to undertake what are usually lengthy scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or are otherwise illegal if companies don't voluntarily comply. . . .FDA's response to the use of DMAA illustrates the challenges that the agency faces in addressing incidents involving potentially dangerous dietary supplements. "

Andrew Weil, one of the USA's best known advocates of holistic medicine, says he also favors closer regulation of supplements.

"I would love to see the FDA set up a division of natural therapeutic agents," says Weil, director of the Arizona Center for Integrative Medicine at the University of Arizona,

But Steve Mister, president and CEO of the Council for Responsible Nutrition, notes that supplement regulations, while "not identical to pharmaceuticals" are "very rigorous."

"Consumers can have strong confidence in the products they're buying," says Mister, whose group represents the supplement industry. "There are lots of ways that the FDA oversees the safety of these products."

The FDA sets standards for good manufacturing processes, Mister notes.

While a supplement may claim to "support immune health," the FDA forbids supplement manufacturers from making specific claims about being able to "treat, diagnose, cure or alleviate the effects of disease." Supplement makers are also required to report "adverse events," such as serious side effects or reactions, to the FDA.

Waxman notes that the FDA has only banned one supplement: ephedra — an herbal stimulant taken off the market in 2004 after it was found to increase the risk of heart problems and death.

Because the FDA's authority is mostly "reactive," Waxman says "the agency must wait for people to get hurt or even die before they can remove an unsafe supplement from the market."

In his book, Offit singles out a number of popular alternative doctors for questionable practices:

• Joseph Mercola, an Illinois physician, sells a variety of supplements and alternative medical products on his web site. Although Mercola shuns vaccines, his website sells tanning beds — which have been found to increase the risk of skin cancer.

In 2011, the FDA sent Mercola a letter for marketing an alternative to mammography on his website — the Meditherm Med2000, a camera that measures skin temperature. Although Mercola's site describes its products as "natural," the FDA viewed the machine as an unapproved medical device.

• Rashid Buttar, a North Carolina physician, has used treatments that Offit calls outlandish. According to the North Carolina Medical Board, those treatments have included giving intravenous hydrogen peroxide to cancer patients and topical chelation creams to children with autism.

In a 2010 consent order with the medical board, Buttar explained that the hydrogen peroxide was intended for "detoxifying the patients and improving their immune systems." In the order, the medical board formally reprimanded Buttar and ordered him to inform all patients that his treatments "may not have been approved by the FDA."

In April, the FDA also sent Buttar a letter, claiming that the claims he made for some of his products showed he was marketing them as drugs, not supplements.

In a post on his website, Buttar noted that he has stopped selling the products mentioned in the FDA letter May 15. One of those products, Trans-D Tropin, previously had been marketed as "a clinically proven aging and longevity solution."

USA TODAY was not able to reach Mercola or Buttar by press time.

• Stanislaw Burzynski, who has spent decades promoting antineoplastons, an experimental cancer therapy not approved by the FDA. According to the National Cancer Institute, these drugs have never been proven effective against cancer in a definitive, randomized, clinical trial.

Last year, the FDA sent Burzynski a letter noting that his "websites violate the Food Drug and Cosmetics Act" because they promoted experimental cancer treatments as "safe and effective."

According to FDA spokesman Curtis Allen, responses to FDA letters are not posted on the agency's website, and are available only through a Freedom of Information Act (FOIA) request. USA TODAY filed a FOIA request but has not yet received a copy of the responses by Mercola, Buttar or Burzynski.

In a statement sent by his attorney, Burzynski said he has published 36 articles, presented papers at many international conferences and completed 14 phase 2 trials in brain tumors. Phase 2 trials consider safety and are a preliminary, but not definitive, look at effectiveness, according to the National Institutes of Health. In the letter, Burzynski wrote that, "based on the results of the phase 2 trials, the FDA has granted permission to proceed into two Phase 3 clinical trials in brain tumors."

Offit also criticizes Mehmet Oz, a respected heart surgeon and star of The Dr. Oz Show, for providing an audience for a variety of questionable guests, from Mercola to faith healers and even psychics.

"He gives a lot of good advice," including advice about diet and exercise, Offit says. "But he mixes that in with a lot of terrible advice."

In a statement, a spokesman for The Dr. Oz Show said the TV program is "a conversation about the many sensitive topics surrounding health care, including alternative medicine, and we remain committed to empowering our viewers with comprehensive information about these issues so they can take an active role in their health."

Yet Cassileth, author of The Complete Guide to Complementary Therapies in Cancer Care, says non-traditional approaches can have a place in medicine, when modern medicine has little to offer.

As opposed to "alternative," Cassileth prefers the term "integrative" medicine, which subjects nonstandard therapies to scientific tests. At Memorial Sloan-Kettering, integrative health researchers focus on alleviating pain and other symptoms. But they would never claim that nontraditional therapies can cure cancer, she says.

For example, doctors have had promising early results using acupuncture to restore salivary gland function in patients who receive radiation to the head and neck. Without functioning salivary glands, these patients can't talk or swallow.

While critics counter that acupuncture treatments are simply placebos, Cassileth says, "if there is a placebo effect that brings back salivation to these people who can't eat or talk, who cares?"